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Gentamicin Sulfate 0.2%/Misoprostol 0.0024%/Phenytoin 5%/Pentoxifylline 5% Topical Cream

The Gentamicin Sulfate 0.2%/Misoprostol 0.0024%/Phenytoin 5%/Pentoxifylline 5% Topical Cream is a specialized compounding formulation designed for the management of complex wound care. This unique combination of active ingredients is incorporated into a semisolid cream base, which is dispensed via a pump mechanism to ensure a consistent and controlled application to the affected skin areas.

Gentamicin Sulfate is an aminoglycoside antibiotic that helps to prevent or treat skin infections in wounds, thereby promoting a more favorable healing environment. Misoprostol, a synthetic prostaglandin, is included for its ability to increase blood flow and promote healing by its vasodilatory and cytoprotective effects. Phenytoin, traditionally used as an anticonvulsant, is utilized in this formulation for its properties in facilitating wound healing, particularly in neuropathic ulcers. Pentoxifylline, a methylxanthine derivative, is added for its role in improving microcirculation and oxygen delivery to the tissues, which is beneficial in treating ischemic skin ulcers.

This topical cream is specifically indicated for the treatment of chronic wounds, including diabetic foot ulcers, venous stasis ulcers, and pressure ulcers, as well as other conditions where improved wound healing is desired. The combination of these four active ingredients in a single formulation provides a multifaceted approach to wound care, addressing infection, blood flow, tissue regeneration, and healing in a targeted manner.

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Topical Cream
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Formula Information

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Our unique compounded formulation combines Gentamicin Sulfate, Misoprostol, Phenytoin, and Pentoxifylline in a topical cream designed to address a variety of skin conditions. Gentamicin Sulfate, at a concentration of 0.2%, is an aminoglycoside antibiotic that provides potent antibacterial properties, particularly effective against a broad range of Gram-negative organisms. This makes it suitable for treating and preventing skin infections in wounds or burns.

Misoprostol, present at 0.0024%, is a synthetic prostaglandin E1 analog. While commonly known for its gastrointestinal protective effects, when used topically, Misoprostol can promote increased blood flow and enhance wound healing by its vasodilatory and cytoprotective actions. This can be particularly beneficial in chronic wounds where blood flow may be compromised.

Phenytoin, at a 5% concentration, is traditionally an anticonvulsant medication, but it has been found to have wound healing properties when applied topically. It can promote granulation tissue formation, reduce wound healing time, and has anti-inflammatory effects, making it useful in the treatment of various ulcers and wounds.

Pentoxifylline, also at a 5% concentration, is a methylxanthine derivative that improves blood flow and has anti-inflammatory properties. It is often used systemically to treat peripheral vascular diseases but has shown promise in topical formulations to improve microcirculation in the skin and enhance the healing of wounds, particularly in the context of stasis ulcers.

The cream is formulated as a semisolid preparation and is dispensed in a pump mechanism, which allows for convenient, controlled, and hygienic application. This delivery system ensures that the correct dose is applied to the affected area, minimizing waste and reducing the risk of contamination. The cream base is designed to facilitate the absorption of the active ingredients into the skin, providing localized treatment directly to the area of concern.

This compounded formulation is intended for use under the guidance of a healthcare professional. It may be prescribed for patients with complex skin conditions that have not responded to conventional treatments, such as diabetic foot ulcers, venous stasis ulcers, pressure ulcers, and other non-healing wounds. The combination of ingredients works synergistically to reduce infection, promote healing, and improve blood flow to the affected areas.

Patients and prescribers considering the use of this formulation should be aware of the potential for side effects and interactions with other medications. It is important to use this cream as directed by a healthcare provider, and it should be applied only to the area prescribed. If you have any questions or require further information about this formulation, please do not hesitate to reach out to us at Bayview Pharmacy. Our team of compounding pharmacists is committed to providing the highest quality of care and is ready to assist with your medication needs.

Drug Interactions

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The formulation you have described contains a combination of active ingredients that are not commonly found together in topical preparations. As such, there is limited specific information on the interactions between these drugs when used in a topical cream. However, we can discuss the potential interactions based on their pharmacological profiles and known systemic interactions when these drugs are used in other forms.

Gentamicin sulfate is an aminoglycoside antibiotic that is used topically to treat bacterial infections of the skin. It is important to note that systemic absorption of gentamicin from topical application is generally low, but it can still occur, especially if applied to large surface areas, in patients with skin disruption, or in those with impaired renal function. Systemic absorption could potentially increase the risk of additive nephrotoxicity and ototoxicity if the patient is taking other medications with similar toxicities, such as loop diuretics or other aminoglycosides.

Misoprostol is a synthetic prostaglandin E1 analog that is used to prevent gastric ulcers and for other gynecological purposes. Its inclusion in a topical formulation is unusual and its effects when applied topically are not well-documented. If systemic absorption occurs, misoprostol could theoretically interact with nonsteroidal anti-inflammatory drugs (NSAIDs) by mitigating their gastric ulcerogenic effects. However, misoprostol could also potentially cause uterine contractions, so it should be used with caution in women of childbearing potential.

Phenytoin is an anticonvulsant that is used primarily for the treatment of epilepsy. When used systemically, phenytoin interacts with a wide range of drugs by inducing hepatic enzymes, potentially decreasing the levels and efficacy of other medications. If systemic absorption of phenytoin occurs from the topical application, it could theoretically interact with drugs metabolized by the same enzymes, such as warfarin, certain statins, and other antiepileptics. Additionally, phenytoin has been associated with cutaneous adverse reactions, which could be exacerbated by the topical application.

Pentoxifylline is a methylxanthine derivative used to improve blood flow in patients with peripheral arterial disease. It has anti-inflammatory and vasodilatory effects. Systemic interactions of pentoxifylline include an increased risk of bleeding when combined with anticoagulants or antiplatelet agents, and additive effects with other blood pressure-lowering agents. If absorbed systemically from the topical application, similar interactions could potentially occur.

Given the complexity of this formulation and the potential for systemic absorption and interactions, it is crucial to monitor patients closely for signs of adverse effects or unexpected drug interactions. Prescribers should be aware of the patient's full medication profile, including over-the-counter drugs and supplements, to assess for potential interactions. Patients should be instructed to report any signs of systemic side effects, such as renal impairment, hearing loss, unusual bleeding, or skin reactions. If you have any questions or require further information, please do not hesitate to reach out to us at Bayview Pharmacy.

How Does it Work

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The Gentamicin Sulfate 0.2%/Misoprostol 0.0024%/Phenytoin 5%/Pentoxifylline 5% Topical Cream is a compounded medication that combines four active ingredients, each with a specific role, to treat various skin conditions. This cream is formulated to be applied topically, where it exerts its effects directly at the site of application. The semisolid preparation is dispensed in a pump mechanism, which allows for convenient, hygienic, and controlled dosing.

Gentamicin sulfate is an aminoglycoside antibiotic that works by inhibiting bacterial protein synthesis, leading to the death of susceptible bacteria. It is effective against a wide range of gram-negative and some gram-positive bacteria. In this cream, gentamicin sulfate is used to prevent or treat skin infections, which can be a complication in wound healing or in skin conditions with a secondary bacterial infection.

Misoprostol is a synthetic prostaglandin E1 analog. While it is commonly known for its gastrointestinal protective and anti-ulcer effects when taken orally, in a topical formulation, misoprostol may help to promote wound healing. It is believed to do so by increasing blood flow and promoting healthy inflammatory responses, which are essential for tissue repair and regeneration.

Phenytoin is an anticonvulsant that also has wound healing properties when used topically. It is thought to work by promoting fibroblast proliferation, collagen deposition, and formation of granulation tissue, all of which are important steps in the wound healing process. Phenytoin may be particularly useful in treating ulcers and other skin wounds that are difficult to heal.

Pentoxifylline is a methylxanthine derivative that improves blood flow by reducing blood viscosity and increasing red blood cell flexibility. In a topical cream, pentoxifylline can enhance blood circulation to the affected area, which can help to deliver oxygen and nutrients essential for healing, reduce inflammation, and potentially aid in the management of conditions like stasis ulcers and peripheral vascular disease.

This unique combination of ingredients in the Gentamicin Sulfate/Misoprostol/Phenytoin/Pentoxifylline Topical Cream works synergistically to treat skin conditions that may benefit from antimicrobial action, enhanced wound healing, and improved blood flow. It is important for patients and prescribers to understand that this is a specialized formulation that should be used under the guidance of a healthcare professional familiar with its indications and application. If you have any questions or require further information about this formulation, please reach out to us at Bayview Pharmacy.

Other Uses

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The present formulation of Gentamicin Sulfate 0.2%/Misoprostol 0.0024%/Phenytoin 5%/Pentoxifylline 5% Topical Cream is primarily used for its wound healing properties, particularly for chronic and non-healing wounds which may be complicated by infection. However, beyond its primary indications, this compound may have other potential therapeutic applications based on the individual effects of its constituents. It is important to note that while we delve into the potential 'other uses' of this formulation, these are not exhaustively researched, and clinicians should use their discretion before prescribing for off-label uses.

Gentamicin Sulfate is an aminoglycoside antibiotic known for its effectiveness against a broad range of gram-negative organisms, and sometimes used for its antibacterial properties to prevent skin infections in burns, minor cuts, or wounds. Misoprostol, an analogue of prostaglandin E1, traditionally used for gastric protection and inducing labor, could theoretically have off-label use in wound care due to its ability to promote increased blood flow and subsequent healing.

Phenytoin, a commonly used antiepileptic, has also been observed to facilitate wound healing, possibly due to its anti-inflammatory effects and promotion of fibroblast proliferation. Pentoxifylline is primarily known as a vascular modifier that improves blood flow, used in the treatment of intermittent claudication. It may be beneficial in improving blood microcirculation in areas affected by wounds and could help reduce inflammation and promote healing.

The combination cream may thus be hypothesized to have use in conditions where increased circulation and wound healing are desirable, such as in diabetic ulcers, pressure ulcers, vascular ulcers, or other ischemic wounds. However, it is imperative that comprehensive clinical examination and judgement are applied before using this formulation for other uses. Due to the complex nature of wound healing and the various patient-specific factors that need to be considered, any off-label use requires close monitoring and should be backed by robust clinical evidence or be guided by a specialist's advice.

In considering these potential secondary applications, one must be aware of the potential for systemic absorption of these drugs and thus the possibility of systemic side effects. Especially in the case of gentamicin, nephrotoxicity and ototoxicity are serious considerations that require vigilance when applying it topically over a large surface area or on areas with compromised skin integrity. The use in pediatric patients, pregnant women, or those with significant comorbidities should be approached with caution and under strict medical supervision.

As compounding pharmacists at Bayview Pharmacy, we are committed to patient safety and the efficacy of our formulations. We strongly encourage prescribers and patients alike to reach out to us with any questions or concerns regarding this specific formulation or its potential other uses. It is through collaborative efforts that we can ensure the safe and effective use of compounded medications for a variety of clinical needs.

Frequently Asked Questions

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What is the purpose of this compounded formulation?

This compounded formulation is designed to deliver a combination of medications directly to the skin for localized treatment. The combination of Gentamicin Sulfate, Misoprostol, Phenytoin, and Pentoxifylline in this cream is often used for their respective properties that may include antibiotic, healing enhancement, anti-inflammatory, and improved blood flow effects.

How should this cream be applied?

The cream should be applied as directed by your healthcare provider. Typically, a small amount is dispensed from the pump mechanism and gently applied to the affected area of the skin. The pump allows for a controlled and uniform dose with each application.

Can this formulation be used on open wounds?

It is essential to follow your healthcare provider's instructions regarding the use on open wounds. Some of the active ingredients may be beneficial for certain types of wounds, but a healthcare professional should assess suitability for this specific formulation.

Is this product suitable for all skin types?

Most patients tolerate this formulation well, but individual sensitivities, such as an allergic reaction, are possible. Consult your healthcare provider before using this product, especially if you have sensitive skin or a history of skin reactions.

How often should the cream be applied?

The frequency of application will depend on the specific condition being treated and the instructions provided by your health care provider. Do not alter the prescribed regimen without consulting them.

Does this cream have any known side effects?

Like all medications, this compounded cream may cause side effects, though not everyone experiences them. Side effects can include skin irritation, redness, or an allergic reaction. If you notice any adverse effects, contact your healthcare provider.

How should I store this topical cream?

Store the cream at room temperature, away from direct sunlight and heat. Do not freeze the cream, and keep the pump mechanism tightly closed when not in use to prevent contamination and ensure the integrity of the medicine.

Can this formulation be used with other medications?

Before applying this cream, inform your healthcare provider about all other medications you are using. There may be potential interactions that could affect the effectiveness or safety of either treatment.

What should I do if I miss an application?

If you miss an application, apply the missed dose as soon as you remember. However, if it's almost time for your next dose, skip the missed dose and resume your usual dosing schedule. Do not double up to make up for a missed application.

Is this cream safe for children?

The safety and effectiveness of this compounded formulation in children have not been established. It should only be used in children if prescribed and closely monitored by a healthcare provider.

Can this cream be used during pregnancy or breastfeeding?

The safety of this formulation during pregnancy or breastfeeding has not been firmly established. Use during pregnancy or while breastfeeding should be discussed with your healthcare provider to weigh potential benefits and risks.

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Formulas and/or material listed are not to be interpreted as a promise, guarantee or claim of therapeutic efficacy or safety. The information contained herein is not intended to replace or substitute for conventional medical care, or encourage its abandonment. Every patient is unique, and formulas should be adjusted to meet their individual needs.

No compounded medications are reviewed by the FDA for safety or efficacy.